Label: HERBALIFE SKIN PROTECTIVE MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51785-899-00, 51785-899-01 - Packager: Herbalife International of America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, epecially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients Water (aqua), Butylene Glycol, Dimethicone, Glyceryl Stearate, Carthamus Tinctorius (Safflower) Oleosomes, Potassium Cetyl Phosphate, PEG-100 Stearate, Glycerin, Isoamyl Laurate, Isodecyl Neopentanoate, Niacinamide, Ascorbyl Glucoside, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Physalis Angulata Extract, Caprylic/Capric Triglyceride, Diisopropyl Sebacate, Lauryl Lactate, Dimethicone Crosspolymer, Carbomer, Xanthan Gum, Fragrance (Parfum), Triethanolamine, Sodium Citrate, Citric Acid, Disodium EDTA, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HERBALIFE SKIN PROTECTIVE MOISTURIZER SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51785-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.9711 g in 30 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1.56 g in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.515 g in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.8505 g in 30 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.8 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) ISOAMYL LAURATE (UNII: M1SLX00M3M) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) LAURYL LACTATE (UNII: G5SU0BFK7O) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) XANTHAN GUM (UNII: TTV12P4NEE) TROLAMINE (UNII: 9O3K93S3TK) SODIUM CITRATE (UNII: 1Q73Q2JULR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51785-899-00 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2014 2 NDC:51785-899-01 15 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2014 Labeler - Herbalife International of America Inc. (873035968)
